1. Field of the Invention
The field of the present invention is safety-sheathed needles.
2. Background of the Invention
The field of the present invention relates generally to apparatus and methods for protection against an accidental sharps injury or stick from an unprotected needle.
For some time, the art has recognized the desirability of protecting personnel from accidental sharps injuries or needle sticks. More recently, concerns have been expressed about the possibility of transmitting serious or potentially fatal infection as a result of such accidents. Most recently, legislation requiring the use of safe needle technology is pending in a number of States and before the Occupation Safety and Health Administration. Although the art has recognized the desirability of protecting against accidental sharps injuries or needle sticks, it is believed that practical protective devices are still not available, particularly for phlebotomy devices that utilize large containers that are not retained with the needle after the blood sample is obtained.
A typical blood collection container is a xe2x80x9cvacutainer,xe2x80x9d which is essentially a short test tube with a hermetic seal at the open end, and containing a vacuum. To collect blood, the operator uses a phlebotomy needle with sharpened points on each end, inserts one end into a patient""s vein, and inserts the other end through the vacutainer seal. The vacuum pulls blood into the vacutainer for a sterile blood sample. The vacutainer is then separated from the needle, and the vacutainer""s seal closes tight enough to retain the liquid blood. But the needle has two sharp ends, and requires careful handling to avoid injury and the spread of blood-borne disease.
To help prevent needle injuries, European Patent No. 0 862 A1 discloses a device in which a needle is retracted into a syringe. In several of the embodiments, the device requires the user to independently operate a mechanical device to cause retraction of the needle. In the one embodiment that utilizes an elastic member, the elastic member is not preloaded and requires the user to depress the plunger to load the elastic member and thereafter continue to apply pressure on the plunger to avoid premature withdrawal of the plunger. As such, the device requires two hands for its operation.
Various methods of providing a preloaded retraction assembly which permit one hand operation are disclosed in co-owned PCT Application No. PCT/US97/20646, International Publication No. WO 98/20923. Although these devices operate successfully, the retraction member is in a tensioned, preloaded condition.
A final concern is the re-use of phlebotomy needles, which can cause disease transmission if the needles are not properly cleaned and sterilized between uses. Such re-use can be accidental if the technician is not careful to dispose of the needle after use.
Accordingly, there is a need for a sheathed phlebotomy needle that can be operated conveniently with one hand, stored in a non-tensioned condition, and constructed to minimize the opportunity for multiple uses.
The present invention is directed to improved sheathed needle phlebotomy (blood sampling) devices. A shuttle having a needle mounted thereto is retracted within a hollow body to safely store the needle. The hollow body has a generally longitudinally extending slot. A pusher element slides with the shuttle and extends through the slot for advance of the needle from the end of the hollow body. An interference element cooperates with the shuttle to retain the needle extended from the hollow body for use. A cap is positioned at one end of the hollow body to receive vacutainers.
In a first separate aspect of the present invention, an elastic band is coupled with the shuttle and the cap. This coupling allows for the band to be substantially unstressed before use, stretched upon needle deployment and operative to retract the needle upon activation.
In a second separate aspect of the present invention, the slot in the hollow body is facing tangentially of the body with the pusher element extending from the slot and movable through the slot circumferentially with rotation of the shuttle in the hollow body. This movement of the pusher element through the slot circumferentially can act to limit reuse.
In a third separate aspect of the present invention, the pusher element can be rotated to release the interference element. This allows automatic retraction of the shuttle under the influence of the elastic band.
In a fourth separate aspect of the present invention, a rotation impedance element may be used to prevent accidental rotation of the pusher element. This prevents accidental release of the interference element and retraction of the needle.
In a fifth separate aspect of the present invention, the pusher element can be disengaged from the shuttle to activate the needle retraction mechanism. This can act to limit reuse.
Accordingly, it is an object of the present invention to provide an improved safety cover for a phlebotomy needle. Other and further objects and advantages will appear hereafter.